Strength of evidence (strong, moderate, weak) definitions are repeated at the end of "Major Recommendations" field.
There is strong evidence to support the use of low-dose tricyclic medications, such as amitriptyline and cyclobenzaprine, as well as cardiovascular exercise, cognitive behavioral therapy (CBT), patient education, or a combination of these for the management of fibromyalgia syndrome (FMS). There is moderate evidence that tramadol, selective serotonin reuptake inhibitors (SSRIs), serotonin and epinephrine reuptake inhibitors (SNRIs), and certain anticonvulsants are effective but the complete results of some trials are not available and systematic reviews have not been reported. Moderate evidence exists for the efficacy of strength training exercise, acupuncture, hypnotherapy, biofeedback, massage, and warm water baths. Many of the commonly used FMS therapies have not been carefully evaluated. Based on these reports, a stepwise FMS management guideline can be recommended.
Stepwise Fibromyalgia Management
Step 1
- Confirm the diagnosis.
- Explain the condition.
- Evaluate and treat comorbid illness, such as mood disturbances and primary sleep disturbances.
Step 2
- Trial with low-dose tricyclic antidepressant or cyclobenzaprine
- Begin cardiovascular fitness exercise program.
- Refer for cognitive behavior therapy or combine that with exercise.
Step 3
- Specialty referral (e.g., rheumatologist, physiatrist, psychiatrist, pain management)
- Trials with selective serotonin reuptakes inhibitors, serotonin and norepinephrine reuptake inhibitors, or tramadol
- Consider combination medication trial or anticonvulsant.
The FMS diagnosis first must be confirmed and the condition explained to the patient and family. Any comorbid illness, such as mood disturbances or primary sleep disturbances, should be identified and treated. Medications to consider initially are low doses of tricyclic antidepressants or cyclobenzaprine. Some SSRIs, SNRIs, or anticonvulsants may become first-line FMS medications as more RCTs are reported. All patients with FMS should begin a cardiovascular exercise program. Most patients will benefit from CBT or stress reduction with relaxation training.
A multidisciplinary approach combining each of these modalities may be the most beneficial. Other medications such as tramadol or combinations of medications should be considered. Patients with FMS not responding well to these steps should be referred to a rheumatologist, physiatrist, psychiatrist, or pain management specialist.
Treatment of Fibromyalgia Syndrome
Medications
Strong Evidence for Efficacy
- Amitriptyline: often helps sleep and overall well-being; dose, 25-50 mg at bedtime
- Cyclobenzaprine: similar response and adverse effects; dose, 10-30 mg at bedtime
Modest Evidence for Efficacy
- Tramadol: long-term efficacy and tolerability unknown; administered with or without acetaminophen; dose, 200-300 mg/d
- Serotonin reuptake inhibitors (SSRIs):
- Fluoxetine (only one carefully evaluated at this time): dose, 20-80 mg; may be used with tricyclic given at bedtime; uncontrolled report of efficacy using sertraline.
- Dual-reuptake inhibitors (SNRIs):
- Venlafaxine: 1 RCT ineffective but 2 case reports found higher dose effective
- Milnacipran: effective in single randomized control trial (RCT)
- Duloxetine: effective in single RCT
- Pregabalin: second-generation anticonvulsant; effective in single RCT
Weak Evidence for Efficacy
- Growth hormone: modest improvement in subset of patients with FMS with low growth hormone levels at baseline
- 5-Hydroxytryptamine (serotonin): methodological problems
- Tropisetron: not commercially available
- S-adenosyl-methionine: mixed results
No Evidence for Efficacy
- Opioids, corticosteroids, nonsteroidal anti-inflammatory drugs, benzodiazepine and nonbenzodiazepine hypnotics, melatonin, calcitonin, thyroid hormone, guaifenesin, dehydroepiandrosterone, magnesium.
Nonmedicinal Therapies
Strong Evidence for Efficacy (Wait-List or Flexibility Controls But Not Blinded Trials)
- Cardiovascular exercise: efficacy not maintained if exercise stops
- CBT: improvement often sustained for months
- Patient education: group format using lectures, written materials, demonstrations; improvement sustained for 3 to 12 months
- Multidisciplinary therapy, such as exercise and CBT or education and exercise.
Moderate Evidence for Efficacy
- Strength training, acupuncture, hypnotherapy, biofeedback, balneotherapy
Weak Evidence for Efficacy
- Chiropractic, manual, and massage therapy; electrotherapy, ultrasound
No Evidence for Efficacy
- Tender (trigger) point injections, flexibility exercise
Definitions
Strength of Evidence
Strong - positive results from a meta-analysis or consistently positive results from more than 1 randomized controlled trial (RCT)
Moderate - positive results from 1 RCT or largely positive results from multiple RCTs or consistently positive results from multiple non-RCT studies
Weak - positive results from descriptive and case studies, inconsistent results from RCTs, or both
